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Study of Premenstrual Syndrome and Premenstrual Dysphoria
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001177
  Purpose

The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).

Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.


Condition
PMS
Premenstrual Mood Disorder
PMDD
Depression

MedlinePlus related topics: Depression Premenstrual Syndrome
U.S. FDA Resources
Study Type: Observational
Official Title: The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavioral Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1100
Study Start Date: August 1981
Detailed Description:

The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses. This will be accomplished by means of clinical interviews, self-rating scales, and periodic evaluation of mood and endocrine function.

We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrine/neurophysiologic studies (companion protocols) in an attempt to identify endocrinologic or physiologic measures that might: 1) be associated with the discrete changes in mood and behavior; 2) distinguish this group from a group of age-matched controls; 3) allow for further subgroup definition on the basis of predicted response to pharmacological intervention.

Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria: 1) history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity-that is, disturbances that are distant in appearance and associated with a notable degree of subjective distress; 2) a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles; 3) age 18-50; 4) not pregnant and in good medical health; 5) regular menses.

EXCLUSION CRITERIA:

Subjects who do not meet the criteria listed above but who do not meet diagnosis criteria for recurrent brief depression will also be studied. The criteria for recurrent brief depression include the following: 1) dysphoric mood or loss of increase or pleasure; 2) duration less than two weeks; 3) four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness; 4) impairment in usual occupational activities; 5) at least one-two episodes per month over one year.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001177

Contacts
Contact: Linda Simpson-St. Clair, R.N. (301) 496-9576 simpsonl@irp.nimh.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 810126, 81-M-0126
Study First Received: November 3, 1999
Last Updated: September 9, 2008
ClinicalTrials.gov Identifier: NCT00001177  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mood
Depression
Cognition
Menstrual
Neuroendocrine
Genetics
PMDD
PMS Premenstrual Syndrome
MRMD Menstrually Related Mood Disorder

Study placed in the following topic categories:
Depression
Menstruation Disturbances
Mental Disorders
Mood Disorders
Depressive Disorder
Premenstrual Syndrome
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009